The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter.
| Device ID | K110385 |
| 510k Number | K110385 |
| Device Name: | ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Asifa Vonhof |
| Correspondent | Asifa Vonhof ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-10 |
| Decision Date | 2011-03-25 |
| Summary: | summary |